The U.S. Food and Drug Administration (FDA) is responsible for regulating medical devices, including accessories that are used to support or enhance their use. But what exactly constitutes an FDA medical device accessory?
Medical accessories are different from device components. According to the FDA, a medical device accessory is a finished device intended to support, supplement, and/or augment the performance of one or more parent devices. If the accessory’s label, promotional materials, or other evidence of intended use indicate that the medical accessory is intended to support, supplement, and/or augment another device, it’s considered a medical device accessory.
For example, let’s say an infusion pump system includes the pump and a stand to support the pump’s performance by holding medications and liquids at a height that’s convenient for the patient or caregiver. The stand would be considered a medical accessory to the pump, and the infusion pump would be identified as the parent device.
The FDA classifies a medical accessory based on its risks when used as intended and regulatory controls necessary to provide reasonable assurance of the accessory’s safety and effectiveness. To classify an accessory, the parent device manufacturer must address the following two questions with the FDA:
The answers to these two questions inform the risk and regulatory control-based classification
of a potential FDA medical device accessory.
Medical accessories have an important role in the healthcare industry, so it’s important that they’re properly classified according to their risk to patient health and safety. The FDA’s Accessory Classification Request process ensures that all medical accessories are reviewed and classified according to their risk.
An Accessory Classification Request is a written request submitted to the FDA for the proper classification of a new or existing medical accessory.
For new accessory types, the New Accessory Classification Request must be included in a premarket approval (PMA) or 510(k) submission for a new medical device. This will make sure the accessory type is properly classified, along with the parent device, under the Federal Food, Drug, and Cosmetic Act before being brought to market.
An existing accessory type is one that has been previously classified, cleared under a premarket notification, or approved for PMA. In this case, a manufacturer or importer can submit an Existing Accessory Classification Request as a standalone request. This request is separate from any PMA or 510(k) application.
If you’re requesting approval for an existing accessory, the FDA typically grants or denies the request within 85 days. For new accessories, the FDA will make its decision concurrently with the decision on the parent device. Once an accessory is approved, the FDA publishes a final classification order in the Federal Register providing public notice of the decision. That way, stakeholders can see the accessory’s classification type to get an understanding of specific requirements it must meet.
If the FDA doesn’t agree with the recommendation for classification submitted in a request, they will not make the submission and associated decision public. However, the FDA will provide a written response to the submitter, including the basis for denying the request.
A parent medical device is a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.
Accessories, like other device classifications, can impact the parent device, and may even possess unique risks independent of the parent device. To assess the risk of an accessory, the FDA will evaluate how it affects the parent device and any other risks it may present. The regulatory controls necessary to manage the risks will be taken into consideration when determining the regulatory class for accessories
The UDI requirements apply to all medical devices per 21 CFR 801.20, including medical accessories, unless an exception or alternative applies or was granted pursuant to 21 CFR 801.30 or 801.55.
There are no distinct Medical Device User Fee Amendments (MDUFA) associated with an Accessory Classification Request. However, if the request is submitted as part of a 510(k) or PMA application, the fees for the 510(k) or PMA application still apply.
As an experienced medical device manufacturer with a line of disposable devices, Remington knows a thing or two about submitting requests for FDA approval. When you partner with us to manufacture a medical device, we take care of everything, from consulting and assembly to final packaging. We can also manufacture any components or accessories your device requires, too.
As your manufacturer of record, Remington designs and manufactures high-quality medical devices on your behalf, ensuring each compliance and regulatory requirement is met along the way. We take manufacturing seriously and hold ourselves to a high standard. If questions arise regarding your product or accessory’s manufacturing process, we gladly step up to clear any confusion, supplying the right documentation to ensure that there’s no issues with your product’s manufacturing process.
Contact us today to learn more about our proven contract manufacturing process.
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